Screening Women With Prior HPV for Anal Neoplasia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-02

Study Completion Date

2027-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this single arm trial is to prospectively evaluate screening methods for anal cancer precursors in HIV uninfected women with a history of lower genital tract neoplasias and cancers.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Biospecimen Collection and Testing for the Prevalence of Anal Dysplasia and Anal Cancer in Patients With Cervical, Vaginal and Vulvar Dysplasia and Cancer

NCT02140021

Cervical Adenocarcinoma Cervical Adenocarcinoma In Situ Cervical Intraepithelial Neoplasia +52 more

TERMINATED NA

Detecting HPV DNA in Anal and Cervical Cancers

NCT04857528

Cervical Cancer Anal Cancer HPV-Related Anal Squamous Cell Carcinoma +3 more

SUSPENDED

Anal Cancer Risk In Women

NCT05835947

Anal Cancer Human Papilloma Virus Anal Intraepithelial Neoplasia +2 more

UNKNOWN

HPV Infection and Vaginal Microecology in Immunosuppressed Women

NCT06619743

HIV Infections HPV Infection Cervical Cancer +1 more

NOT_YET_RECRUITING

Screening for HPV and Cervical Cancer in Young Women With Perinatally Acquired HIV

NCT04587050

HIV Infections Human Papillomavirus Infection Cervical Cancer

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This single arm trial will enroll 300 HIV uninfected women with a history of genital neoplasia (ie., cervical intraepithelial neoplasia grade 2-3, vaginal intraepithelial neoplasia grade 2-3 or vulvar intraepithelial neoplasia grade 2-3) or early stage cervical or vulvar cancer to evaluate the test characteristics of anal cancer screening tests (cytology, HPV testing and high resolution anoscopy) and determine the prevalence and incidence of anal high-grade squamous intraepithelial lesions in this population. Participants will undergo evaluation at baseline and then at 12 and 24 months. The investigators will also measure the acceptability of anal cancer screening in this previously unstudied group. The trial is expected to run from 2021-2027.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HPV-related Lower Genital Tract Neoplasias HPV-related Anal Neoplasias Early Stage Lower Genital Tract Cancers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Women With Prior HPV for Anal Neoplasia

Standard of care anal cancer screening with anal cytology, HPV testing and high resolution anoscopy.

Group Type EXPERIMENTAL

Diagnostic tests for anal cancer screening

Intervention Type DIAGNOSTIC_TEST

The initial screening interventions will include the collection of (1) anal cytology; (2) self-collected HPV testing specimens (by subjects); (3) a clinician collected HPV specimen. A digital rectal exam will also be done on all patients.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Diagnostic tests for anal cancer screening

The initial screening interventions will include the collection of (1) anal cytology; (2) self-collected HPV testing specimens (by subjects); (3) a clinician collected HPV specimen. A digital rectal exam will also be done on all patients.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Women with a history of pathologically proven high-grade genital HPV-associated neoplastic disease (cervical intraepithelial neoplasia 2+, vulvar intraepithelial neoplasia 2+, or vaginal intraepithelial neoplasia 2+, or history of non-metastatic cervical, vaginal or vulvar cancer)
* Documented HIV seronegativity
* Aged 35 years and older
* Seen in the Mount Sinai Health System (MSHS) or the Harris Health System (HHS) in Houston
* English or Spanish speaking